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Tag: biotechnology


Clinical Trials, Industry, Research and Development, Vaccines

Study demonstrates safety and efficacy of co-administering COVID-19 and flu vaccines

June 16, 2021

Via: Pharma Times

The study, co-authored by Seqirus, was conducted as part of a Phase III clinical trial of Novavax’s COVID-19 vaccine NVX-CoV2373 in the UK. The co-administration sub-study enrolled a total of 431 volunteers, all of whom had received a flu vaccine […]


Cell and Gene Therapy, Industry

Germany approves legislation to improve cell & gene therapy availability

June 15, 2021

Via: EPM Magazine

The parliament advocated for an increase in the number of NUB inquiries that can take place each year. NUB inquiries are used by hospitals to gain short term reimbursement for innovative treatment and diagnostic methods, supplementing the standard Diagnosis Related […]


Cell and Gene Therapy, Industry

Biogen’s inherited eye disease gene therapy misses the mark in late-stage trial

June 15, 2021

Via: Pharma Times

The Phase III STAR study enrolled 169 adult males with a genetically confirmed diagnosis of choroideremia. It evaluated the safety and efficacy of a single subretinal injection of the investigational gene therapy. The primary endpoint was the proportion of patients […]


Industry, News, Vaccines

Pfizer’s COVID-19 Vaccine Protects Against SARS-CoV-2 Variants

June 14, 2021

Via: Genetic Engineering and Biotechnology News

The good news about vaccines and variants continues to roll in. Last week, a study reported that Johnson & Johnson’s COVID-19 vaccine protected against all of the SARS-CoV-2 variants of concern. Now, Pfizer’s COVID-19 vaccine has been shown to protect […]


FDA, News, Regulations

J&J must ditch 60m COVID jabs made at US plant, but 10m are okay, says FDA

June 14, 2021

Via: Pharmaphorum

The problems at the plant run by contract manufacturer Emergent BioSolutions first emerged a few weeks ago, after an FDA inspection uncovered a string of violations including that the building was “not maintained in a clean and sanitary condition.” While […]


Industry, Vaccines

NCCN experts provide new guidance on COVID-19 vaccines for cancer patients

June 11, 2021

Via: Medical News

The National Comprehensive Cancer Network (NCCN) today announced the publication of new guidance on COVID-19 vaccines for people with cancer, intended to clear up confusion for patients and caregivers. The new four-page patient guide is based on the latest expert […]


FDA, Industry, News, Vaccines

Ocugen gets a black eye as FDA denies emergency OK for COVID jab

June 11, 2021

Via: Pharmaphorum

That will hold back the biotech’s Covaxin shot by several months, and the delay put pressure on Ocugen’s share price, which fell more than 25% after the announcement. The Philadelphia-based company said it had taken the decision to go down […]


Industry, News, Vaccines

Study links AstraZeneca COVID-19 shot to bleeding disorder ITP

June 10, 2021

Via: Pharmaphorum

The scientists examined real-world public health data from all individuals in Scotland who received either the AZ or Pfizer/BioNTech vaccines up until 14 April and found a possible association between the AZ shot and an autoimmune disorder called idiopathic thrombocytopenic […]


Mergers and Acquisitions, News

Merck signs $1.2bn supply deal with US government for Molnupiravir

June 9, 2021

Via: PMLiVE

The treatment, being developed by Merck in collaboration with Ridgeback Biotherapeutics, is currently being evaluated in a phase 3 clinical trial. The trial, know as the MOVe-OUT study, is evaluating molnupiravir in the treatment of non-hospitalised patients with laboratory-confirmed COVID-19 […]


Cell and Gene Therapy, Industry

Beigene expands into cancer cell therapy with Shoreline pact

June 9, 2021

Via: Biopharma Dive

Beigene has quickly become a force in cancer drug development, earning approvals in the U.S. and China for its targeted therapy Brukinsa and immunotherapy tislelizumab. The biotech is developing a slate of small molecule and antibody drugs aimed at several […]


Manufacturing, Research and Development

After COVID-19 spotlighted supply chain weaknesses, Biden unveils plan to resurrect U.S. drug manufacturing

June 8, 2021

Via: FiercePharma

After investigating America’s supply chains, including those for drugs and pharmaceutical ingredients, the Biden administration has revelations to share—and it’s proposing a sweeping strategy to boost domestic drug production. Under the plan, the White House is establishing a public-private partnership […]


Biotech, Industry

Biotech raises $1.4 million to accelerate drug delivery technology

June 8, 2021

Via: EPM Magazine

CyGenica raised the money in a seed fund investment round led by global venture capital investor SOSV. CyGenica will use the funding to accelerate the validation of its technology which is designed to enable safe, targeted and affordable intercellular drug […]